AIM:
The
aim of the study is to determine the efficacy of systemically administered
combination of proteolytic enzymes and their timings in third molar surgery.
OBJECTIVES:
1. Evaluate efficacy of proteolytic enzymes used as a fixed
dose combination in this study in terms of pain and swelling in the immediate
post operative period.
2. Evaluate whether any specific time for example before
surgery or after surgery of administration of proteolytic enzymes changes the
outcome and post opeartive sequelae.
3. Evaluate whether the outcome also changes when
proteolytic enzymes are used concomitantly with non steroidal anti inflammatory
drugs.
4. Evaluate the quality of life of patients after third
molar surgery with and without administration of proteolytic enzymes.
PATIENTS
& METHOD:
Source of data:-
The patients will be selected from the
OPD of the dept. of OMFS, NHDC, Mumbai, whose informed consent will be taken prior
to the procedure. A maximum number of
200 patients with partially impacted mandibular third molars requiring surgical
extraction will be selected.
Inclusion
criteria:
1.
Any patient with an partially impacted
mandibular third molars (upto Level B,
as per the Pell and Gregory scales)
and indicated for its surgical extraction.
2.
Any patient who willingly gives consent for
the being involved in the study
3.
Healthy adult patients in the age group of
18-40 years.
Exclusion criteria:
1. Pregnant
females and Lactating mothers.
2. Patients
who had/have any periapical or odontogenic lesion associated with the impacted
tooth.
3. Patient
known to be allergic to any constituent of the proteolytic drug combination.
4.
Patients with a known allergy to co-amoxiclav
group or NSAID drugs.
5. Patients with any underlying systemic
condition/medication which will interfere with drug metabolism.
6. Patients on immunosuppresants.
7. Interincisal opening
less than 3 cms.
PROCEDURE:
Patients will be selected from OPD of
NHDC, Mumbai. Detailed case history will be taken. Pre- operative medical &
radiographic investigations will be done & informed consent will be taken.
All patients who are willing to participate in the
study and are fit as per the inclusion criteria will be consecutively recruited
in the study. However, the distribution of a particular patient into a
particular group will be done on a random basis. The patients will be randomly
divided into the four groups using a randomisation generator from http://www.randomization.com/ that randomizes each subject into single treatment
by using the method of randomly permuted blocks
Total
Number of patients – 200
Number
of operating surgeons – 1
Patients
will be randomly divided in four groups (50 patients in each group).
All partially impacted mandibular third molars (upto Level B as per Pell and
Gregory Scales) requiring surgical extraction presenting to the OPD will be
selected for the study.
After
obtaining informed consent from the patient for the surgical procedure patients
will be kept blind about the group they are placed in. Operator who performs
the surgery is blind to the group that the patient is allotted in, observer is
blind to the medicines that the patient has received.
Patients
will be sent for preoperative assessment of Hemoglobin, bleeding and clotting
time and an intraoral periapical radiograph of the impacted mandibular third
molar (if IOPA is not feasible then a lateral oblique view of the mandible will
be taken).
Antibiotics
having action over gram positive organisms (Amoxycillin 500mg three times a
day) and NSAID’s (Diclofenac 50 mg and Paracetamol 500mg three times per day)
available on the MCGM supply register will be provided to the patient as per
his group/subgroup; if there is shortage of the same then the investigators
shall bore the cost of the same.
|
Group ( Half
an Hour Before meals)
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I – Antibiotics7 + Proteolyitc enzymes
(started 48 hrs prior to surgery and continued for 3 days post surgery)
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II – Antibiotics + Proteolyitc enzymes (started on
the day of surgery and continued for 5 days post surgery)
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III – Antibiotics + Proteolyitc enzymes (started immediately
after surgery and continued for 5 days post surgery)
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IV – Antibiotics + Proteolyitc enzymes + NSAID’s1
(started 6 hours after surgery and continued as a 5 day post surgery
regimen)
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Clinical
Parameters:
1.
Proteolytic
enzymes will be started 48 hours before surgery and continued 72 hours post
surgery in group 1.
2.
In
group III and IV no preoperative
therapy will be initiated and it will be given only postoperatively. The first
dose of the drug will be given immediately
after the surgery in group III and
continued thereafter for next 5 days at an eight hourly interval.
3.
Pain
will be evaluated by Visual Analog Scale on 1st day, 5th
day, 7Âth day after surgery. Use of analgesic
will be recorded.
4.
Facial
swelling will be evaluated by measuring distance between 6 predetermined points
on 1st day, 5th day, 7Âth day after surgery. The points will be
Canthus (Cn) to Gnathion (Gn), corner of the mouth (Cm) to tragus of the ear
(Tr) and Pogonion (Pg) to tragus (Tr).
5.
Post
operative quality of life of the patients will be evaluated on the basis of a
questionnaire which is prepared and patients will be asked to fill it up on 7th
post-op day.
6.
Any
other complications related to the surgery/lesion will be recorded. |